Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
Background Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduc...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
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| author | Qi Wang Yuqi Jia Xuecheng Zhang Yujiang Dong Zhihui Hou Wenqi Deng Menghe Zhang Qiurun Mu Hongling Jia |
| author_facet | Qi Wang Yuqi Jia Xuecheng Zhang Yujiang Dong Zhihui Hou Wenqi Deng Menghe Zhang Qiurun Mu Hongling Jia |
| author_sort | Qi Wang |
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| description | Background Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation.Methods This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial.Discussion This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV.Ethics and dissemination The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible.Trial registration number ChiCTR 2100042646; Chinese Clinical Trial Registry. |
| format | Article |
| id | doaj-art-9071612a91604b84b037fdff184fcf2d |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-9071612a91604b84b037fdff184fcf2d2025-08-20T02:27:11ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-068318Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trialQi Wang0Yuqi Jia1Xuecheng Zhang2Yujiang Dong3Zhihui Hou4Wenqi Deng5Menghe Zhang6Qiurun Mu7Hongling Jia83 Artificial Cell Engineering Technology Research Center, Tianjin, ChinaCollege of Acupuncture and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, ChinaKey Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Cardiology, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaDepartment of Radiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College/ National Center for Cardiovascular Diseases, Beijing, ChinaDepartment of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Cardiology, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaCollege of Acupuncture and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, ChinaDepartment of Acupuncture and Moxibustion, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaBackground Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation.Methods This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial.Discussion This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV.Ethics and dissemination The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible.Trial registration number ChiCTR 2100042646; Chinese Clinical Trial Registry.https://bmjopen.bmj.com/content/12/12/e068318.full |
| spellingShingle | Qi Wang Yuqi Jia Xuecheng Zhang Yujiang Dong Zhihui Hou Wenqi Deng Menghe Zhang Qiurun Mu Hongling Jia Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial BMJ Open |
| title | Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial |
| title_full | Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial |
| title_fullStr | Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial |
| title_full_unstemmed | Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial |
| title_short | Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial |
| title_sort | acupuncture assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting ponv study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/12/e068318.full |
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